First-in-Human Safety, PK, and Food Effect Study of Single Ascending Doses of G1T38 in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

First-in-Human Phase 1 Safety, Pharmacokinetic, and Food Effect Study of Single Ascending Doses of G1T38 in Healthy Male and Female Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02821624
• Other study ID #: G1T38-01
• Secondary ID: 2016-001201-17
• Status: Completed
• Phase: Phase 1
• First received: June 28, 2016
• Last updated: June 13, 2017
• Start date: May 2016
• Est. completion date: April 4, 2017

Study information

• Verified date: June 2017
• Source: G1 Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This first-in-human (FIH) study will provide the first safety and pharmacokinetic (PK) data for G1T38 in humans and will allow further development of G1T38 in patients with cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: April 4, 2017
• Est. primary completion date: December 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy male and female volunteers, 40-65 years of age; no clinically significant findings reported following detailed physical examination, medical history, vital signs, clinical laboratory tests, and ECGs as deemed by the PI

• Body mass index (BMI) in the range of 18 to 32 kg/m2 (inclusive) at screening, and weighing at least 50 kg

• Nonusers of nicotine-containing products for at least the previous 3 months prior to dosing or nonsmokers

• Agreement to use birth control during the study and 3 months post last visit.

• Able to comply with all protocol requirements and procedures

Exclusion Criteria:

• Clinically significant abnormalities found during physical examinations, medical history review, ECGs (QTcF interval > 450 milliseconds for males and >470 milliseconds for females), vital signs, and laboratory tests (including positive HIV, hepatitis B and C)

• Participated in in a previous clinical study with an investigational product in the last 60 days

• History of any serious allergic reaction to any medication

• Any blood or plasma donation or other loss of blood at a volume exceeding 500 mL within 3 months before dosing

• History of drug or alcohol abuse in the last 2 years

• Pregnant or lactating women

• Any other issues which, in the opinion of the PI, will make the subject ineligible for study participation

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• G1T38 (CDK 4/6 Inhibitor)
CDK 4/6 Inhibitor
• Placebo
Placebo

Locations

Country	Name	City	State
Netherlands	PRA Early Development Clinic	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
G1 Therapeutics, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Treatment Related Adverse Event, including Abnormal Laboratory Events	All AEs, including clinical laboratory, vitals signs, physical examinations and ECGs will be analyzed in all subjects receiving study drug through 7 days post dose of study drug.	Up to Day 7
Secondary	Pharmacokinetics of G1T38: Maximum Plasma Concentration (Cmax)	The observed peak plasma concentration determined from the plasma	Day 1, 2, 3, 4 and 5
Secondary	Pharmacokinetics of G1T38: Area under Curve - plasma concentration (AUC)	Area under the plasma concentration-time curve	Day 1, 2, 3, 4 and 5
Secondary	Pharmacokinetics of G1T38: Plasma: terminal half life (T1/2)	G1T38: Plasma- terminal half life (T1/2)	Day 1, 2, 3, 4 and 5
Secondary	Pharmacokinetics of G1T38: Plasma - Volume of distribution	Volume of distribution in the terminal elimination phase	Day 1, 2, 3, 4 and 5